AffloVest® Mobile Airway Clearance Therapy

AffloVest® Mobile Airway Clearance Therapy is an FDA 510(k)-cleared medical device (K252849) manufactured by Tactile Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2026. Regulation: 8.